Compound W® N/A

GUDID 00075137110571

COMPOUND W® COMPLETE WART KIT Maximum Freeze Plantar and Stubborn Warts

MEDTECH PRODUCTS INC.

Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit

• Primary Device ID: 00075137110571
• NIH Device Record Key: 4f18e3fb-d489-43c4-b1eb-84b726b13df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compound W®
• Version Model Number: CW066101; CW066601; CW066201; CW066501
• Catalog Number: N/A
• Company DUNS: 060272465
• Company Name: MEDTECH PRODUCTS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx
• Phone: 18004434908
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰F (50⁰C). Store at room temperature away from heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075137110571 [Primary]
GS1	10075137110578 [Package]; Contains: 20075137110575; Package: shipping carton [2 Units]; In Commercial Distribution
GS1	20075137110575 [Package]; Package: inner pack [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151309

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-09

On-Brand Devices [Compound W®]

• 10075137530055: Maximum Freeze Freeze Off® Wart Remover System
• 10075137440347: Maximum Freeze Freeze Off® Plantar Kit Wart Removal System
• 00075137110854: COMPOUND W® DUAL POWER (2-in-1 Treatment Kit for Large Warts)
• 00075137110571: COMPOUND W® COMPLETE WART KIT Maximum Freeze Plantar and Stubborn Warts
• 00075137108257: Accu-Freeze® Freeze Off® Advanced Wart Removal System
• 00075137000032: Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System
• 10075137000145: Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System - yellow carton secondary sku